Other substances

GX-19

A COVID-19 candidate DNA vaccine.

Phase of research

Potential treatment - pre-clinical evidence

How it helps

Vaccine

Drug status

Experimental

2
 Supporting references
0
 Contradictory references
1
 AI-suggested references
4
 Clinical trials

General information

GX-19 is a candidate vaccine being developed by Genexine. lt is a DNA-based vaccine encoding synthetic soluble SARS-CoV-2 Spike protein. GX-19 displayed immunogenicity in mice and non-human primates. A reduction of viral loads was observed in vaccinated non-human primates after a viral challenge compared to control (Seo et al., 2021). Currently, this COVID-19 candidate vaccine is in Phase I/II of clinical evaluation. 

Synonyms

pGX27-SΔTM

 

Supporting references

Link Tested on Impact factor Notes Publication date
Draft landscape of COVID-19 candidate vaccines
healthy adults Jul/28/2020
Soluble Spike DNA Vaccine Provides Long-Term Protective Immunity against SARS-CoV-2 in Mice and Nonhuman Primates
Spike protein DNA Animal model Mixed substance 		BALB/c mice; Cynomolgus macaques; SARS-CoV-2 National Culture Collection for Pathogens accession number 43326 4.09

The vaccine displayed immunogenicity in mice (Spike-specific antibody response and Th1-biased T cell response) and non-human primates (neutralizing antibody response and CD4+ and CD8+ T cell responses). A relative reduction of viral loads and improvement in infection symptoms were observed compared to control in vaccinated non-human primates after a viral challenge.

 Mar/24/2021

AI-suggested references

Link Publication date
Safety and immunogenicity of two recombinant DNA COVID-19 vaccines containing the coding regions of the spike or spike and nucleocapsid proteins: an interim analysis of two open-label, non-randomised, phase 1 trials in healthy adults
Feb/08/2022

Clinical trials

ID Title Status Phase Start date Completion date
NCT04445389 Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults Active, not recruiting Phase 1|Phase 2 Jun/17/2020 Mar/30/2022
  • Alternative id - GX-19-HV-001
  • Interventions - Drug: GX-19|Drug: Saline
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Severance hospital, Seoul, Korea, Republic of
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 60
  • Age - 18 Years to 50 Years   (Adult)
  • Outcome measures - Incidence of solicited adverse events|Incidence of unsolicited adverse events|Incidence of serious adverse events|Geometric mean titer (GMT) of antigen-specific binding antibody titers|Percentage of subjects who seroconverted after vaccination|Geometric mean titer (GMT) of neutralizing antibody level|Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers
NCT04715997 Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults Active, not recruiting Phase 1|Phase 2 Dec/30/2020 Jun/30/2022
  • Alternative id - GX-19N-HV-002
  • Interventions - Drug: GX-19N|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - KyungHee University Medical Center, Seoul, Korea, Republic of|Severance Hospital, Seoul, Korea, Republic of|Hanyang University Hospital, Seoul, Korea, Republic of|Gangnam Severance Hospital, Seoul, Korea, Republic of|Ajou University Hospital, Suwon, Korea, Republic of
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 170
  • Age - 18 Years to 55 Years   (Adult)
  • Outcome measures - Incidence of Solicited Adverse Events|Incidence of Unsolicited Adverse Events|Incidence of Serious Adverse Events|GMT of Antigen-specific Binding Antibody Titers|GMFR of Antigen-specific Binding Antibody Titers|Percentage of Subjects Who Seroconverted After Vaccination|GMT and GMFR of Neutralizing Antibody Level|GMFR of Neutralizing Antibody Level|GMSN and GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay
NCT05067946 Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines Not yet recruiting Phase 2|Phase 3 Oct/01/2021 Oct/01/2023
  • Alternative id - GX-19N-HV-004
  • Interventions - Biological: GX-19N|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
  • Enrollment - 14000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - First occurrence of COVID-19 at least 14 days after the second vaccination|Incidence of severe solicited adverse events (AEs)|Incidence of AEs and Serious AEs (SAEs) after each vaccination|Incidence of SAE, and Adverse events of special interest (AESIs), which relevant to COVID-19 including possible vaccine-enhanced disease|First occurrence of severe COVID-19 at least 14 days after the second vaccination|Cell-mediated immune responses after vaccination|Antibody responses after vaccination
NCT04915989 Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals Active, not recruiting Phase 1 Feb/16/2021 Mar/31/2022
  • Alternative id - GX-19N-HV-003
  • Interventions - Drug: GX-19N
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Severance hospital, Seoul, Korea, Republic of|Gangnam Severance hospital, Seoul, Korea, Republic of
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 30
  • Age - 55 Years to 85 Years   (Adult, Older Adult)
  • Outcome measures - Incidence of Solicited Adverse Events|Incidence of Unsolicited Adverse Events|Incidence of Serious Adverse Events|GMT of Antigen-specific Binding Antibody Titers|GMFR of Antigen-specific Binding Antibody Titers|Percentage of Subjects Who Seroconverted After Vaccination|GMT of Neutralizing Antibody Level|GMFR of Neutralizing Antibody Level|GMSN of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay|GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay
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